GAMP 5 and 21 CFR Part 11, Compliance with Computer System Validation

I take this opportunity to invite you for GAMP5 & 21CFR Part 11 Compliance with Computer System Validation which is going to be held in Goa on 29th & 30TH April 2017.

Easy way for Pharma Company to Stay Compliant.

Training of GXP to vendor.

Training to Purchase as they still believe in Root Cost instead of Root Cause.

Selection of Good Third Party Consultant and Listen to them Take action against staff who tries to put company in trouble by a shortcut Create a Quality Culture Motivate staff for taking right action If management do not take action against 5% bad people 75% fence sitter will become bad. 20% are always good.

Have Earlier Internal Audit as soon as 483-warning letter is received Increase frequency of CAPA, Periodic Review and Change Control- Audit Trail Review plus more...

Focus on selection of staff.

Taught through classroom presentations, workshop sessions, and team exercises, the course will present an overview of Part 11 including its objectives, benefits, and potential problems. This will be followed by a detailed analysis of Part 11 requirements, a discussion of electronic records and signatures, and key industry issues.

Quality is like Aathma to Body. Industry Leader says the same.

Purchase, IT, QA, Validation, Engineering and All other need to learn it by heart.

The Trainer for the program would be the expert from the Bio Pharma Industry Mr.Kalpesh Vaghela. He has 30 year Global Job/business Experience.11 year dedicated Software Validation Experience for a CSV consultancy in India and Abroad. Four to Six year Trainer Experience.

https://www.linkedin.com/in/kalpesh-vaghela-08876561/

https://www.linkedin.com/in/k-r-vaghela-58352756/

And he would be speaking on Topics such as.

Ø Why the need for Validation came in to picture? History of Validation

Ø Benefits of Validation Ø How we can get Good System

Ø How validation helps to improve your business

Ø Computer Validation as per GAMP5

Ø Why Validation? Deliverables of the Validation...And many more.

Could you please let me know your interest for being a part of the training program?

Team Discount: For every three paying registration from your company will receive a fourth complementary* registration to the training (*Application for full training on standard price).

Please don’t hesitate to contact if you have any questions.

Thanks & regards

Mackenzie Carvalho

Delegate Acquisition Executive

E: sales@sunriseforums.com

M: +91 9867000616

W: www.sunriseforums.com